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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Medical Device Notification: HIV-1/HIV-2 Plus O EIA Testing Software-DiaSporin, Inc



May 13, 2004




HIV-1 / HIV-2 Plus O EIA Testing Software



DiaSorin, Inc
Stillwater, Minnesota




An error was contained on the ETI-LAB Applications disk for programming the BioRad HIV-1/HIV-2 Plus O assay. The error induced specimen and conjugate incubation temperatures for the assay to remain at ambient temperature rather than the required 37°C temperature. Consignees will receive replacement disks.



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Food and Drug Administration

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